Clinical trial · Interventional
Irofulven in Treating Patients With Metastatic Breast Cancer
Phase II Study of MGI-114 in Patients With Metastatic Breast Cancer
NCT00003796CI-TRIAL-00009421completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irofulven | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: irofulven
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the breast * Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy * Must have received 1 or 2 prior chemotherapy regimens for metastatic disease * More than 3 prior regimens allowed * No active brain metastases or meningeal breast cancer involvement PATIENT CHARACTERISTICS: Sex: * Male or female Performance status: * SWOG 0-2 Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases) Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No history of myocardial infarction or unstable angina within the past 6 months * No uncontrolled congestive heart failure Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease) * No history of retinopathy and/or macular degeneration PRIOR CONCURRENT THERAPY: Chemotherapy: * No prior irofulven
References
Publications (0)
Data not yet available
No reference posted for this study.